Overall Survival Analysis From a Randomized Phase II Study of Axitinib With or Without Dose Titration in First-Line Metastatic Renal Cell Carcinoma

Brian I. Rini, Yoshihiko Tomita, Bohuslav Melichar, Takeshi Ueda, Viktor Grünwald, Mayer N. Fishman, Hirotsugu Uemura, Mototsugu Oya, Angel H. Bair, Glen I. Andrews, Brad Rosbrook, Eric Jonasch

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27 Citations (Scopus)

Abstract

Background: In a randomized phase II trial in metastatic renal cell carcinoma (mRCC), objective response rate was significantly higher with axitinib versus placebo titration (54% vs. 34%; 1-sided P = .019). Patients and Methods: Treatment-naive patients with mRCC (n = 213) received axitinib 5 mg twice per day (b.i.d.) for 4 weeks. Patients meeting dose titration criteria were randomized to receive axitinib 5 mg b.i.d. with axitinib or placebo titration (n = 56 each); 91 patients ineligible for randomization continued axitinib 5 mg b.i.d.; 10 discontinued before randomization. Results: Median overall survival (95% confidence interval [CI]) was 42.7 months (24.7-not estimable) with axitinib titration versus 30.4 months (23.7-45.0) with placebo titration (stratified hazard ratio, 0.785; 95% CI, 0.485-1.272; 1-sided P = .162), and 41.6 months (95% CI, 33.0-not estimable) in nonrandomized patients. Safety data were consistent with previous reports. Conclusion: Median overall survival was numerically longer in patients with first-line mRCC who received axitinib versus placebo titration. No new safety signal was observed after long-term axitinib treatment in first-line mRCC.

Original languageEnglish
JournalClinical Genitourinary Cancer
DOIs
Publication statusAccepted/In press - 2016 Feb 17

Keywords

  • First-line treatment
  • Kidney cancer
  • MRCC
  • Phase II
  • VEGFR inhibitor

ASJC Scopus subject areas

  • Oncology
  • Urology

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    Rini, B. I., Tomita, Y., Melichar, B., Ueda, T., Grünwald, V., Fishman, M. N., Uemura, H., Oya, M., Bair, A. H., Andrews, G. I., Rosbrook, B., & Jonasch, E. (Accepted/In press). Overall Survival Analysis From a Randomized Phase II Study of Axitinib With or Without Dose Titration in First-Line Metastatic Renal Cell Carcinoma. Clinical Genitourinary Cancer. https://doi.org/10.1016/j.clgc.2016.04.005